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FMS3 Facility Monitoring System for Pharmaceuticals

The FMS Monitoring Software is a comprehensive, networked data collection, storage and reporting system. FMS supports a wide range of industry standard instrumentation and can be readily adapted to support specialized equipment. FMS is developed and maintained under a GAMP4 and ISO 9001-2000 regime. It enables the implementation of 21 CFR Part 11 compliant systems.

  • Multiple Sensor Inputs
    Sensors can be integrated into one system, leading to support from a single supplier and reducing overall maintenance costs.

  • Easy to Use
    A simple Graphical User Interface clearly displays real time data. This makes the system easy for operators to use, which reduces training requirements, provides a positive user experience and, ultimately, improves process control.

  • Robust Monitoring
    The FMS Buddy is a hot stand-by, fully configured monitoring system that is able to take over the full monitoring task should the main computer fail, leading to no downtime, no data loss and total peace of mind.

  • Modular Architecture
    The FMS Compact is a dedicated networked monitoring computer that can be installed in a remote instrument cabinet. This frees office space and allows the real time data to be viewed using existing computer systems. When a system expansion is undertaken, the modular system design means that a complete system re-validation is not required, thereby minimizing future validation costs.



Features
  • Industry Standard Interfaces
    - Includes OPC and MODBUS

  • Secure Standard SQL Databases
    - Includes Microsoft SQL, MySQL, Borland Interbase, PostgreSQL and ODBC
    - Only main program has access to database.
    - Mirror databases are supported.
    - Supports multiple clients from single database.

  • Audit Trails
    - Activity Reports
    - Provisions for Details
    - End User Acknowledgement System for System Changes & Alarms
    - Audit Trail Logs
    - Logs of Alarms, Events or Audit Activities
    - Revision of Configuration Files

  • Alarms and Alerts
    - 4 Levels of Alarm Support
    - Alarm Levels Trigger Different Conditions and Events
    - Group Alarms

  • Batch Reports
    - Batch History Reports
    - Screen View and Printout of Resulting Data
    - Historical Reports
    - Identification of Alarm Limits
    - Automatic Report Generation

  • 21 CFR Part 11 and PAT
    - Supports Implementation of the Pharmaceutical Industry’s FDA 21 CFR Part 11 and PAT

  • Robust and Resilient Design
    - FMS detects and heals errors, automatically recovering from a wide range of fault conditions including total failure of hardware.

  • Distributed Design
    - Resists substantial hardware faults and makes installation and upgrading easier.

  • International
    - FMS readily adapts to local languages.

  • GAMP Compliant Design
    - Developed using a GAMP4 compliant life cycle
 
FMS Components
1 X FMS Compact
(2 - 150 sample points)
Includes the embedded FMS Facility Monitoring System Software
and ONE FMS Client license to allow data to be viewed locally.
Expansion to increase the number of sample points is available.
FMS-2 FMS-30
FMS-4 FMS-50
FMS-10 FMS-100
FMS-20 FMS-150
 
FMS Configuration Options
1 x FMS - Client FMS Client Facility Monitoring Software Suite, Client License, Windows 95/98/NT/2000, and XP OS; enables remote access to the monitoring system. FMS-Client
1 x FMS Buddy Buddy system - price not dependent on the number of sample points. FMS-Buddy
1 x FMS Mirror Mirror Database. FMS-Mirror
1 x Batch Manager FMS Module to track product batches. FMS-Batch
1 x OPC Module to support OPC interfaces. FMS-OPC
Particle Counter Download Enhanced system capability. FMS-Particle
1 x BMS support Modbus/TCP
interface
This allows connection of an FMS system to a building management system. FMS-BMS
1 x MySQL Licensed Database license. FMS-MYSQL
1 x PDF reporting Allows reports to be generated as Adobe PDF files. FMS-PDF
 
Operating Systems (Client/Server):
Microsoft Windows 98, NT, 2000, XP

STANDALONE SYSTEM
NETWORK SYSTEM
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